Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
Reported: July 30, 2014 Initiated: May 23, 2014 #Z-2102-2014
Product Description
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
Reason for Recall
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 34,470 units
- Distribution
- Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 34,470 units.
Why was this product recalled? ▼
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2102-2014.
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